Class: Eye, Nose and Ear
Dosage Form: Various
Description: Anti-inflammatory and antibacterial agent
Manufacturer: Amoun Pharma
Each ml of drops or 1 gram of ointment contains:
Genatmicin sulphate…………………………………………..3 mg
Prednisolone acetate…………10 mg (drops) or 6 mg (oint)
Apigent-P eye or ear drops and ointment contain a combination of antibiotic (gentamicin sulphate) and a corticosteroid (prednisolone acetate).
Gentamicin sulphate, an aminoglycoside, is a bactericidal against many strains of Gram negative microorganisms as; Neisseria sepcies, Moraxella, Escheria coli, Pseudomonas aeuroginosa and Seeatia narcesens and some Gram positive organisms as; Staphylococcus species and Streptococcus species.
Prednisolone acetate, a corticosteroid, is an anti-inflammatory antiallergic agent indicated for steroid-resposive inflammatory conditionsof palpebral and bulbar conjunctiva, cornea and anterior segment of the eye and that of the external ear canal and/or middle ear (e.g. suppurative otitis media).
Generally, this combination is used for conditions for which corticosteroid is indicated, and a bacterial infection or a risk of bacterial infection exists.
- Inflammatory conditions of conjunctiva, cornea and anterior segment of the eye where steroid use is accepted to obtain a diminution of edema and inflammation
- Chronic anterior uveitis and corneal injury from chemicals, radiations or foreign bodies
- Lesions in the external ear canal, such as acute or chronic otitis externa, eczematoid dermatitis, seborrheic dermatitis and contact dermatitis infected with microorganisms
- Suppurative otitis media
Apigent-P is contraindicated in case of:
- Hypersensitivity to any of the ingredients or to other corticosteroids
- Viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritis keratitis), vaccinia and varicella and also mycobacterial infection of the eye and fungal diseases of the ocular structure
- Viral infections of the ear
Dosage and Administration:
1. For the Eye:
- Instill 1-2 drops into the conjunctival sac 2-4 times daily during the initial 24-48 hours
- The dosing frequency may be increased, if necessary, up to 1 drops every hour or as directed by the physician
- Ointment: Apply either at night (if eye drops were used during the day), or 3-4 times daily if ointment is being used alone, or as directed by the physician
2. For the Ear:
- Drops: Instill 3-4 drops, 3-4 times daily or as directed by the physician
- Ointment: Apply either at night (if drops were used during the day) or 2-3 times daily if ointment is being used alone, or as directed by the physician
Pregnancy and Lactation:
Use in pregnancy only if potential benefits outweigh potential risks.
Ocular irritation and punctate keratitis have been associated with the use of drops. Renewal of the medication should be made only by a physician. Intraocular pressure should be routinely monitored.
Should not be prescribed for undiagnosed red eyes, which may be caused by herpes simplex virus.
As fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration.
If inflammation or pain of the eye persist longer than 48 hours or become aggravated, the patient should be advised to dicontinue use of the medication and consult a physician.
Do not use the same bottle for simultaneous eye and ear infections to avoid contamination and/or cross infection. Contamination of the solution may occur if the dropper touches any surface.
Safety for children less than 6 years has not been established.
Drops: Dropper bottles of 5 ml.
Ointment: Tubes of 5 g.
Store at room temperature, below 25°C.